NEW YORK -- Paradigm Spine, LLC, a developer of innovative
non-fusion and fusion spinal implant solutions, announced today that it
has completed patient enrollment in an Investigational Device Exemption ("IDE") pivotal clinical study comparing the coflex[R]
interlaminar technology to instrumented posterolateral fusion in the
surgical treatment of spinal stenosis. Data from this trial will be used
to support the coflex[R] interlaminar technology Pre-Market Approval
("PMA") application. The study is a prospective, randomized
and concurrently controlled clinical study involving more than 380
patients at 21 sites within the United States. The coflex[R] technology,
with over 15 years of clinical heritage outside the U.S., has been
implanted in more than 50,000 patients, and is selling in over 40
countries worldwide.

The coflex[R] technology is a minimally invasive, non-fusion
implant that allows movement of the spine in both flexion and extension,
while providing interlaminar stabilization, foraminal distraction and
facet distraction. The coflex[R] is a U-shaped titanium alloy surgical
device which is implanted in the interlaminar space following a surgical
decompression. The coflex[R] is being evaluated in the United States for
use in patients with moderate to severe spinal stenosis, isolated to 1
or 2 levels, in the region of the first to the fifth lumbar vertebrae,
specifically L1 to L5.

Dr. Reginald J. Davis, Chief of Neurosurgery at Greater Baltimore
Medical Center and an investigator in the study explained, "Since
the coflex[R] device is a functionally dynamic non-fusion implant, it
will provide spine surgeons with the option of utilizing a less
invasive, tissue sparing procedure while affording patients significant
pain relief all without having to resort to fusion. I look forward to
having the coflex[R] device as part of the 'arsenal' of
surgical options for relief of pain due to spinal stenosis."

"This is a very exciting time and a significant milestone for
Paradigm Spine", said Marc R. Viscogliosi, Chairman and CEO of
Paradigm Spine, LLC. "We are grateful to those patients and their
families who have consented to be involved in this clinical study as it
represents the first U.S.-based prospective, randomized, multi-center
spinal stenosis study comparing a non-fusion interlaminar device to a
posterolateral fusion. We are very grateful to our investigators and
clinical care teams for their support throughout enrollment and as we
continue to follow these patients through the completion of the
trial."

About Lumbar Spinal Stenosis

Lumbar spinal stenosis affects more than 2 million people in the US
and millions more worldwide. It is defined as the narrowing of the
spinal canal, which may place pressure on the spinal cord or nerves, and
occurs mostly in the middle-aged and elderly population. This
debilitating disease causes severe back & leg pain which gets worse
with time, leaving the patient in a state of constant pain and sometimes
immobilization. Currently, the "gold standard" surgical
treatment for patients who have lumbar spinal stenosis, in conjunction
with minor instability and/or significant back and leg pain, is a
surgical decompression of the diseased segment of the spine, followed by
pedicle screw fusion. This procedure, although generally successful in
alleviating the patient's leg and back pain, causes significant
morbidity and a lengthy recovery time for the patient, in addition to a
permanent loss of motion in the fused segment of the spine.

About Paradigm Spine, LLC

Paradigm Spine is a company focused on the design, development and
marketing of innovative non-fusion solutions for the treatment of spinal
conditions and diseases. The company's mission is to provide only
"Best in Class" products and services to Spine Surgeons and to
be above all, "Surgeon Centric, Indication Specific and Data
Driven".

The company is concentrating on building a multi-product non-fusion
portfolio. The company's signature product is the coflex([R])
interlaminar/interspinous functionally dynamic stabilization device,
currently being used in over 40 countries. The company is currently
conducting an IDE clinical trial of the coflex([R]) implant in the
United States.

The FDA cleared the company's DSS[TM] system in 2008, which is
the company's first product to be marketed in the United States.
Paradigm Spine's wholly owned subsidiary, Fourth Dimension Spine is
developing a portfolio of non-fusion scoliosis implant technologies and
a family of predictive diagnostic technologies for scoliosis. In
addition to coflex[R] and DSS[TM], Paradigm Spine commercially markets
two additional spinal implants internationally -DCI[TM], and
coflex-F[TM]

For more information please visit: www.paradigmspine.com

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